The global payer landscape is experiencing seismic shifts steered by a few policy transformations and advent of new policies. This evolving payer landscape is expected to potentially impact pricing and market access (P&MA) strategies of pharmaceutical companies, for their new launches or optimisation of existing portfolios, owing to stricter evidence expectations, growing emphasis on demonstrating real-world evidence of a product’s value to the healthcare system and patients and adaptations to Health Technology Assessments (HTAs) and regulatory frameworks.
Access Infinity team considers how these dynamically evolving payer policies will affect pharmaceutical manufacturers and patients’ access to innovative therapies across global markets in 2025 and beyond. This year certainly is at crossroads between opportunities and challenges for the pharmaceutical industry, hence it becomes crucial for the manufacturers to monitor, adapt the policy dynamics and adopt forward-thinking strategies to thrive and effectively navigate in this evolving environment.
Access Infinity closely analysed three key payer policies from the perspective of P&MA implications for pharmaceutical manufacturers, focusing on how they can strategize to seize opportunities and address challenges.
Trend #1. GERMANY: Proposed Amendment to AM-NutzenV – Integrating EU Joint Clinical Assessments
The German Federal Ministry of Health has introduced a draft amendment to the Pharmaceutical Benefit Assessment Regulation (AM-NutzenV), aligning Germany’s national benefit assessment framework with the new EU Joint Clinical Assessment (JCA) process under the EU HTA Regulation, effective January 2025. The proposed changes aim to harmonise timelines and processes while maintaining Germany’s high standards for evaluating therapeutic and economic value.
Trend #2. GERMANY: End of International Reference Pricing (IRP) as part of Medical Research Act
Germany has officially eliminated International Reference Pricing (IRP) as a factor in drug pricing under the Medical Research Act. Previously, Germany used a weighted IRP model that incorporated actual selling prices in other European countries, adjusted for purchasing power parity (PPP) and turnover share. This allowed external price benchmarking in AMNOG negotiations.
The removal of IRP means Germany’s role as a pricing anchor in Europe and globally will shift, impacting countries that reference German prices (e.g., Canada, Japan, South Korea). However, Germany will likely remain a key market for indirect price referencing given its early-launch status.
Trend #3. CANADA: Aligned reviews between Health Canada and Health Technology Assessment organisations
Health Canada (HC) released a notice, effective immediately, to the industry regarding aligned reviews between Health Canada and health technology assessment organisations (CDA and INESSS). To ensure the shortest possible interval between regulatory approval and HTA recommendation, sponsor should note that:
- HC’s Priority Review takes around 180 days thus it is advised to file HTA submissions immediately after HC accepts the submission
- HC’s advance consideration for NOC/c pathway submission review target is 200 days thus HTA submissions should be filed within 3 weeks after HC accepts the submission
- HC’s Standard review completion target is 300 days thus HTA submissions should be filed within 4 months after HC accepts the submission
Proactive Planning & Agile Adaptation: Pharma Strategy for Market Access and Pricing with Changing Payer Policy Dynamics
The pharmaceutical industry is facing a whirlwind of change. Dynamic market conditions, intricate pricing regulations, and evolving payer policies across the globe are creating a complex landscape. To thrive, pharmaceutical companies must ditch reactive measures and embrace a new paradigm: proactive planning coupled with agile adaptation.
Why Proactive Planning is No Longer Optional: In today’s environment, pharmaceutical companies need to initiate early planning to truly understand the impact of market-specific payer policies and identify opportunities and mitigate any challenges.
Agility: The Key to Navigating Shifting Sands: Amidst the constantly evolving global payer landscape, evidence expectations and competitive pressures intensify while new regulations emerge. Hence, agility and flexibility are no longer just buzzwords; they are essential for navigating through these complicated waves.
Turning Complexity into Opportunity: Navigating this complex landscape requires a partner who can provide clarity and guidance. Access Infinity acts as a key enabler, helping pharmaceutical companies actively track and understand the global payer landscape and foster cross-functional synergies between market access, pricing, clinical, and commercial teams thereby, strengthening value proposition to achieve successful access and pricing for innovative therapies.
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Authored by
Nikhil Taxak, Ph. D, APAC Head, Pricing and Market Access Data and Analytics*
Simran Godhwani, Associate Consultant
Samrudhi Mansukh, Analyst, Data Team
Monisha Palanisamy, Senior Analyst, Data Team
Mahesh Jaju, Associate Manager, Data Team
David McConkey, Partner
Brett Gardiner, Senior Partner*
All authors represent Access Infinity
*Corresponding authors: nikhil@accessinfinity.com and brett@accessinfinity.com
